Microbicides
Trial: Safety and acceptability of dapivirine gel, conducted using daily monitored adherence in healthy HIV-negative women [IPM 014A]
Phase: I/II
Product Being Tested: Dapivirine gel
Sponsor, funder, developer, collaborator:International Partnership for Microbicides
Total participants: 320
Countries: Kenya, Malawi, Rwanda, South Africa
Trial sites in South Africa: Brits, North West Province; Cape Town, Western Cape;
Ladysmith, KwaZulu Natal; Paarl, Eastern Cape; Pinetown, KwaZulu Natal
Results expected: n/a
For more information: http://clinicaltrials.gov/ct2/show/NCT00917904?term=IPM014B&rank=1
Trial: Dapivirine vaginal gel safety [IPM 014B]
Phase: I/II
Product Being Tested: Dapivirine vaginal gel
Sponsor, funder, developer, collaborator: International Partnership for Microbicides
Total participants: 320
Countries: South Africa
Trial sites in US: n/a
Results expected: n/a
For more information: http://www.clinicaltrials.gov/ct2/show/NCT00917904?term=dapivirine+gel&rank=3
Trial: Dapivirine vaginal ring safety [IPM 015]
Phase: I/II
Product Being Tested: Dapivirine vaginal ring
Sponsor, funder, developer, collaborator: International Partnership for Microbicides
Total participants: 280
Countries: South Africa, Kenya, Malawi, Rwanda, Tanzania
Results expected: n/a
For more information: http://www.clinicaltrials.gov/ct2/show/NCT01071174?term=dapivirine+vaginal+ring&rank=1
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Pre-Exposure Prophylaxis
Trial: Pre-Exposure Prophylaxis Initiative [iPrEx]
Phase: III
Product Being Tested: Daily oral TDF/FTC (Truvada®)
Sponsor, funder, developer, collaborator: National Institute of Health, Bill and Melinda Gates Foundation, Fenway Community Health, San Francisco Department of Public Health
Total participants: 2,499
Countries: Brazil, Ecuador, Peru, South Africa, Thailand, US
Trial sites in US: Boston, MA
Results expected: Announced in Q4 2010. For more information visit the
Global iPrEx page or
AVAC's iPrEx page
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PrEP & Microbicides
Trial: Vaginal and Oral Interventions to Control the Epidemic [VOICE (MTN 003)]
Phase: IIb
Product Being Tested: Daily oral TDF; daily oral TDF/FTC; daily topical tenofovir gel
Sponsor, funder, developer, collaborator:Microbicide Trials Network, National Institutes of Health
Total participants: 5,000
Countries: Malawi, South Africa, Uganda, Zimbabwe
Trial sites in South Africa: Durban, KwaZulu Natal; Klerksdorp, Johannesburg
Results expected:2013
For more information: http://www.mtnstopshiv.org/news/studies/mtn003
Trial: Adherence and pharmacokinetics study of oral and vaginal preparations of tenofovir [MTN-001]
Phase: IIb
Product Being Tested: Tenofovir gel, oral TDF
Sponsor, funder, developer, collaborator:Microbicide Trials Network, Division of AIDS/National Institute of Allergey and Infectious Diseases; Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Institue of Mental Health ; Gilead, CONRAD
Total participants: 144
Countries: South Africa, Uganda, US
Trial sites in South Africa: Durban, KwaZulu Natal
Results expected: 2010
For more information: , http://clinicaltrials.gov/ct2/show/NCT00592124?term=MTN-001&rank=1
http://www.mtnstopshiv.org/news/studies/mtn001
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Partner Treatment
Trial: Evaluation of the effectiveness of two antiretroviral treatment strategies to prevent HIV transmission in HIV-serodiscordant couples [HPTN 052]
Phase: III
Product Being Tested: Highly active antiretroviral therapy for HIV prevention
Sponsor, funder, developer, collaborator:HIV Prevention Trials Network, Soweto HPTN, Witwatersrand Clinical Research Site, Helen Joseph Hospital
Total participants: 1,750 couples
Countries: Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, Zimbabwe
Trial sites in South Africa: Johannesburg
Results expected: n/a
For more information: http://www.hptn.org/research_studies/hptn052.asp